Objective: To develop a new sandwich based lateral flow immunochromatographic strip for rapid detection of circulating Schistosoma mansoni antigen in serum and urine samples of patients with active schistosomiasis. Methods: This lateral flow immunochromatographic strip was prepared by using anti-Schistosoma mansoni soluble egg antigen monoclonal antibody conjugated gold nanoparticles (MAb-AuNPs) as antigen-detecting antibody, while crystalline material (MCM)-41-MAb bioconjugate was immobilized at the test line as antigen-capturing antibody. Both antigen capturing and detecting antibodies formed sandwich complexes with circulating Schistosoma mansoni antigen in the positive samples. Sandwich complexes immobilized at the test line gave distinct red color. The assay reliability was examined by using urine and serum samples of 60 Schistosoma mansoni infected patients, 20 patients infected with parasites other than Schistosoma, and 20 healthy individuals as negative controls. Results were compared with those obtained via sandwich enzyme linked immunosorbent assay (ELISA). Results: The detection limit of circulating Schistosoma mansoni antigen by lateral flow immunochromatographic strip was lower (3 ng/mL) than the detection limit by ELISA (30 ng/mL). The sensitivity and specificity of lateral flow immunochromatographic strip in urine samples were 98.3％ and 97.5％, respectively compared to 93.5％ and 90.0％ by ELISA. In serum samples, they were 100.0％ and 97.5％, respectively compared to 97.0％ and 95.0％ by ELISA. The strip test took approximately 10 min to complete. Conclusions: This new lateral flow immunochromatographic strip offers a sensitive, rapid, and field applicable technique for diagnosis of active schistosomiasis.

Objective: To develop a new sandwich based lateral flow immunochromatographic strip for rapid detection of circulating Schistosoma mansoni antigen in serum and urine samples of patients with active schistosomiasis. Methods: This lateral flow immunochromatographic strip was prepared by using anti-Schistosoma mansoni soluble egg antigen monoclonal antibody conjugated gold nanoparticles (MAb-AuNPs) as antigen-detecting antibody, while crystalline material (MCM)-41-MAb bioconjugate was immobilized at the test line as antigen-capturing antibody. Both antigen capturing and detecting antibodies formed sandwich complexes with circulating Schistosoma mansoni antigen in the positive samples. Sandwich complexes immobilized at the test line gave distinct red color. The assay reliability was examined by using urine and serum samples of 60 Schistosoma mansoni infected patients, 20 patients infected with parasites other than Schistosoma, and 20 healthy individuals as negative controls. Results were compared with those obtained via sandwich enzyme linked immunosorbent assay (ELISA). Results: The detection limit of circulating Schistosoma mansoni antigen by lateral flow immunochromatographic strip was lower (3 ng/mL) than the detection limit by ELISA (30 ng/mL). The sensitivity and specificity of lateral flow immunochromatographic strip in urine samples were 98.3% and 97.5%, respectively compared to 93.5% and 90.0% by ELISA. In serum samples, they were 100.0% and 97.5%, respectively compared to 97.0% and 95.0% by ELISA. The strip test took approximately 10 min to complete. Conclusions: This new lateral flow immunochromatographic strip offers a sensitive, rapid, and field applicable technique for diagnosis of active schistosomiasis.